"Intersect Partner’s selected NSAI for
their Notified Body based on extensive review of their qualifications
and experience with other Notified Bodies. Based on the review,
NSAI was found to be exceptionally cost effective and offered
turn-around times which were significantly more competitive
than other NB’s. While other NB’s promised similar terms,
upon following-up on their references, this was not the case.
In addition, personal experience with other NB‘s of a similar
caliber (lesser class, for lack of a better term) have a lax
view of CE Mark requirements. As Intersect Partner’s is interested
in a long term presence in the EU market, we were interested
in a thorough review of our quality system and product files
to assure we met CE Marking requirements. NSAI was also appealing
as they can provide services for a wide range of product lines,
including complex products which may be covered by multiple
directives. NSAI’s close association with the Competent Authority
gave credibility to effectively discuss conformity issues.
Intersect Partner’s has continued the relationship with NSAI
as NSAI fulfilled its commitment and offers exceptional customer
service. Although some timing issues were had, NSAI was forthright
and responsive. The open communication and excellent working
relationship thus far will keep NSAI as our NB."
Rebecca Pine, Lake Forest, California
Intersect
Partners LLC.
"I wanted to take a moment to thank NSAI as the general
scheduling, review time and communication between Hemcon Medical
Technologies and NSAI has been exemplary in the past few months.
Working in conjunction with the U.S. NSAI office has provided
Hemcon with fastidious scheduling of review dates and provided
a communication bridge between the technical reviewers in
Ireland to support the launch of Hemcon’s products to the
European Community in a timely manner that meets Hemcon’s
business goals and directives in continuing to provide state
of the art medical devices to the European Community. "
Deanna E. Najman, Quality Engineer
HemcCon Medical
Techologies Inc.
"During our Company’s decision process in choosing a
Notified Body for our product distribution in Europe, NSAI
had the best communication commitment for us. This was a key
factor in choosing NSAI as a partner and a service because
previous experience with other Notified Body services had
been disappointing with delays, no or little communication,
and turn over of staff. My experience with NSAI continues
to be excellent and I am positive that we will be working
together for many more years."
Pamela Misajon, Vice President of Regulatory
& Clinical Affairs
Pegasus
Biologics
We were delighted to work with NSAI during the ISO 9001 registration
process. Your technical service is excellent. The auditor
was very proficient, reliable, and knowledgeable. Thank you
for supporting us in our road to ISO 9001:2000 certification".
Dorota Kochmanski, Director of Quality Assurance/Quality
Control
Azure
MicroDynamics, Inc.
"The QC080000 ( RoHS) certification was mandatory for
us to maintain our leader position in the Harness & Cable
assembly industries. The NSAI auditor performed a great audit on
our RoHS processes and proposed some very constructive observations.
We were very good in our understanding of this new specification,
now we are even better. Our RoHS certification is the result of
a dedicated team."
Tommy
Gaudreault, Directeur QA & I.N.P
Triton
Câble
"For the last 10 years, I have worked with NSAI to certify
three companies to either ISO 9001:2000, ISO 140001:2004 or
AS9100B. NSAI service was excellent. Whenever I had a request
or question, NSAI always replied to me in a timely manner.
The NSAI auditors are very professional and perform the audit
thoroughly and worked with me for the improvement of the QMS
or EMS system.”
Dr.
Truc Nguyen, Quality System Director
ProWorks,
Inc.
“NSAI played an important role as an independent registrar
to help our company facilitate and realize our short term
and long term objectives. Our certifications and quality
standards speak volume amongst our customers as well as our
competitors. We now have tangible distinctions that separate
us from our competition when certifying RoHS components, products,
and manufacturing processes.”
Peter Anninos, Syscom Tech
SyscomTechUSA. |